July 24, 2020
The possibility of chemical contamination has prompted Akorn Inc. to recall 33,343 bottles of proparacaine hydrochloride ophthalmic solution 0.5%. According to the July 22, 2020, US Food and Drug Administration (FDA) Enforcement Report, “out-of-specification results [were] obtained for equipment cleaning residue rinse sample.”
The recall affects proparacaine hydrochloride ophthalmic solution 0.5%, 15 mL (NDC 17478-263-12), from lot 9E52A (Exp. 4/21). The bottles were distributed within the United States and Puerto Rico.
Akorn voluntarily initiated the recall December 26, 2019. The FDA designated the recall Class III on July 14, 2020, suggesting use of the affected solution is not likely to cause harm.
Proparacaine is a prescription anesthetic used to numb eyes during surgery, tests, or procedures.